The Central Drugs Standard Control Organisation (CDSCO) is planning to develop a common software platform for all the states in India for online filing and processing of applications for the grant of drug manufacturing licences. The objective is to build a transparent system as well as keep up with global benchmarks. However, the industry experts believe that the move will come with its own sets of challenges as they discuss its pros and cons and offer helpful suggestions. By USHA SHARMA
Manufacturers should get adequately trained to prepare for the new process
The proposal of creating a common software platform for drug licenses management for all the states in the country is a welcome step. it harmonise the licenses issued all over the country. But, it will require support and co-ordination from all state drug control departments as well as manufacturers.
Issue of drug licenses by state drug controllers in time is very important for the survival and growth of the pharmaceutical industry. If there are any delays or glitches in getting online, it can cause hardship to the manufacturers. Further, the staff in the state drug control department needs to be trained in the implementation of the systems and the systems also may require adequate upgradation and speed.
All along, the Indian Drug Manufacturers have been following a conventional path in getting their drug licenses and they have been going on smoothly. Now, the manufacturers also need to get adequately trained to make online application for drug licenses. Many manufacturers are apprehensive that there may be delays in implementation of the new system. Hence, more time needs to be given to them to comply with the new requirements. Initially, it can be made optional and later mandatory, once we arrive at smooth functioning of the system.
The sugam portal launched by the Central Drugs Standard Control Organisation (CDSCO) is running smoothly now except for some glitches in getting receipts for online payments made. While the system is accepting payment, it requires reminders to issue receipts for the payments, which is important for our records. I am sure, this will be sorted out soon.
Success of this portal will depend upon the back-end data
A robust single portal for the online approval in India, to obtain any kind of drug license approval is a great initiative by the CDSCO and Ministry of Health & Welfare. Primarily, implementation and success of this portal will depend upon the back-end data which has been used. We need to have all approved drugs, APIs, their combinations, excipients and dosage to be synchronised in such a way that for any available drug combination in the market if asked for a license should immediately be approved or rejected, based on the parameters and compliance of manufacturing. Apart from that, all the manufacturing units should have the complete online monitoring of manufacturing processes at their plant level, which can be checked by authorities any time, including their quality parameter which cannot be altered by human intervention. The objective of this is, when these processes will be in place, the system itself will approve/reject the three validation batches. That means, who so ever the manufacturer may be the ‘quality’ will be ensured before the standard approval by CDSCO.
Most importantly, to ensure that the manufacturers adhere to the system, a penalty standard should also be set-in. I believe, that the renewal of licenses should be done only if the drug manufactured by the unit for that approved period of license, adheres to 100 per cent compliance and if there is online rejection/recall of three batch any time in this period, that product should not get an approval for that manufacturing unit. This will help in keeping up the quality, ethical and healthy competition, reduce the load on the department and spurious drug manufacturing will automatically brought here to closure.
We should not adopt online system for the approval of “New Drug/Formulation” Now, but we need to continuously work on developing the model and take a call when the system for existing product/combinations becomes robust. The reason behind it is that for a new drug/formulation approval, there is a lot of new data which is generated by the researcher/manufacture. Their data will not be with department in prior, hence requires lots of studies/analyses/discussion before approval. this data can be uploaded so that after approval, it becomes a standard and a reference point for other manufacturers seeking approval. The role of drug inspectors and authorities then becomes very different, then they will be able to utilise their time in developing better processes and give their advice to the manufacturing plant to adhere to better compliance.
Secondly, training and development through the online portal should be the second very important aspect which needs to be considered. There should be a level wise examination to work in a manufacturing/R&D/ any institution where ever the scope of CDSCO goes. Online examinations needs to be conducted to qualify, to work in these units. Every level worker in the manufacturing unit must appear for the examination to qualify to work in the manufacturing unit. It is not the basics Qualification which should be the only criteria. The questions should be objective. But their sequences should be such that people cannot memorise the questions and cannot communicate to the other examines. This is possible when each question is given the time only read and answer, not to think. This will also help the manufactures management in deciding about the career plan and justification of salary to their employees.
I am of the firm opinion that to meet up to the expectation of international standards and survive in future, which is going to be a quality based market, price is not going to be a big factor. Where ever here is price concern to poor, the government should provide free medicines. The govt should focus on quality and not on price. Yes, there should essential drugs which should be in DPCO. I believe, medicines/drugs/formulations should have ONE standard in the world as, the disease is only ONE, across the WORLD. Therefore, there should be one standard, one process, and
one system for the manufacturing/analysis/approval of drugs in the world. Looking into the world’s current approach towards pharma manufacturing, each country is being challenged at all fronts.
Therefore to be in the completion and escalate the pharma business, it is the need of the hour that we up-scale our standards, meeting up to global standards and bring in policies to encourage API manufacturing before 2024.
I am confident that Indian Pharmaceutical Drug Authorities would be certainly working upon standardising the quality standards, matching the Global Standards. We are very hopeful that there will be a positive, digital transformation in the CDSCO online system, which will help improve the system, by adopting robust processes to strengthen the standardisation of the approvals to make India a quality driven country on the map of world of pharmaceutical manufacturing.
A robust e-governance system is the foundation for an effective compliant regulatory framework
As the demand for Indian made pharmaceutical products increases globally, we have a very sure possibility of investment in green field manufacturing and supply facilities. Timely approval and completion will be the key as the market is highly competitive and several other growing economies are competing with India to grab a significant share of global pharma market. We cannot afford to lose any of the opportunities. Moreover, new greenfield capacities mean more direct and indirect employment opportunities.
It is a herculean task for the CDSCO and other ancillary agencies to manually monitor the cGMP status, licencing and various aspects of regulatory compliance for pharma manufacturing and supply. The step taken by CDSCO to bring an e-initiative to streamline the manufacturing licencing centrally through a central data base is a welcome step and need of the hour. India is aggressively pushing for increasing our share in the global pharma market and it is extremely important that we have a e-system of monitoring and governance.
Pharma manufacturing and supply are governed by drug product quality. This means that there needs to be a system of knowing who the approved sources of supply of the medicines are. Apart from knowing the source of supply, it is also to be noted that data should be made available to know the manufacturing capabilities and technology employed. This means an increased emphasis on computerisation and automation of processes of data gathering and data reporting. For any e-system design, development and its launch must help in enforcing the regulations imposed upon the drug manufacturer for 100 per cent compliance to the law of the land.
A robust e-governance system is the foundation for an effective compliant regulatory framework. It is a known fact that a well thought and designed e-governance system helps as follows :
a) Productivity Improvement
b) Simplification in regulatory administration
c) Encourages transparency
d) Removes inconsistency in data & duplication of data
e) Faster licence clearances and regulatory compliances
f) Upgrades from person led to system led
g) Improves data accessibility and security
h) Ready for harmonised data anytime
Some of the important suggestions to plan for successful implementation could be as follows :
a) Creation of a central team with Subject Matter Experts on E System design, development and implementation. Should have industry participation also.
b) Upgrading the software and hardware infrastructure at our central and local FDA centres.
c) Every manufacturer to have a system based unique login and password so that they can upload data on their own.
d) All licences sequence can be based on bar code structure wherein each bar gives some information like, location, date of issue, API/Formulation etc.
e) Common specifications for all the IT infrastructure need across all locations in India.
f) Training of FDA officials in the system software’s for effective monitoring and
compliance.
g) Good internet connections and hardware configuration to reduce any chances of website crashes, data upload issues, etc.
h) The software should be designed as per the latest data integrity guidelines so that the data cannot be compromised in any manner.
i) There should be a planned movement time frame from manual to e-system.
j) Manufactures should be provided easy training via YouTube, Self-Training etc.
k) Central team to help in data sanitisation and remove any corrupt and conflicting data.
l) Regular maintenance of the data and website is essential to improve efficiency.
We need to clearly understand that global pharma market is increasingly moving towards e-system based governance system and India cannot afford to lag. In fact, as the number of manufacturers increases to satisfy the global demand, it is important that the regulatory agencies in the country go for automation and e-governance at faster pace. This will help us to prepare our agencies for handing of volumes of data in a much faster time. Speed and accuracy are the results of a successful implementation of E-system.
New system will enable central control in the true sense
The intention of CDSCO is pragmatic and well thought out. This, if fructified, will enable to control central licensing in the true sense. In order to achieve this, initially Sugam portal was established in 2015. However, Sugam portal has run in to a rough weather. The salient observations are listed below.
1. First and most important is that the Sugam portal of CDSCO is not user friendly. The attempts have been made to improve in this direction, but still there is a room for improvement.
2. There are various home pages of CDSCO for log in for different applications and registration.
3. Application status is not communicated properly. For example, even after the expiry of specific period it shows 0 days left continuously.
4. The documents to be submitted on the portal for specific application do not match with the list given in the D&C Rules
5. Multiple uploading of documents for specific requirement is not possible. Needs combining of documents to one document.
6. The earlier site FDA WHO MAHARASHTRA.GOV.IN and now we need to enter whole data in Sugam portal. So, we need to go for registration in the following manner -Site registration, Licence registration
Product registration – uploading of these details is not going to be cost effective for the manufacturer.
For site registration:
If user is having 4-5 sites, we need different Login E-mail address. If we don’t have, we need to create a new E-mail address. If we use a repeat e-mail for another login it is showing the message user already registered.
For new product registration / Already registered products –in category – there is no provision for Dash and to select Excipients q.s.
7. We need to upload documents of 1-10 MB size, but for uploading 526 KB size also we are getting an error.
Overlooking all the above points, one can see and visualise a colossal amount of work and duplication which will be involved in filing the application by the state software linked to Sugam portal.
It is pertinent here, to monitor that CDSCO will monitor every application so applied by state manufacturer in various parameters like rationale for FDC, BA/BE studies, stability studies and clinical studies if required before approving the license.
Our suggestions are as follows;
1. To make Sugam portal more user friendly through the inputs that are forwarded by the manufacturers.
2. Delegate the colossal work that each state has submitted in terms of application by decentralising the work by appointing the CDSCO officials in every state or employing dedicated supervisors at zonal level.
Regulators should ensure effective dessimnation of information on the new system
The main technical glitch which I am facing is that in Sugam, as a manufacturer, I cannot upload or access the same.
Mainly it is designed for importers, blood banks etc. Though our regulators have asked to upload all or product permissions on SUGAM – we are unable to do it. Regulators need to update the software and also if possible, conduct seminars/ workshops or webinars to disseminate the information. Regulators should disseminate information on the new setup.
The next era of manufacturing technology is likely to be more in the direction of digitalisation
The initiative taken by CDSCO comes with a noble objective of moving towards global best practices. The next era of manufacturing technology is likely to be more in the direction of digitalisation. Regulatory authorities around the globe are moving to digitisation in every aspect of regulations, and are encouraging companies to implement the same. Several global pharmaceutical companies have started implementing IIoT, machine learning, artificial intelligence (AI), block chain, automation and cloud computing in their processes. CDSCO has initiated the step in the right direction. The common software will help in consolidation of data and is expected to bring in transparency of the processes. This will also give a true picture of the total manufacturing sites with the list of products. Gujarat is much ahead in the successful implementation of the computerisation initiatives in regulatory arena and it shall be a role model for other states to follow.
Although the initiation of common software for grant of manufacturing licenses is welcomed, it is likely to face several known and unknown issues for successful implementation based on not so pleasant past experience of such initiatives. SUGAM portal is still not entirely adopted by all manufacturers even after four years of its notification. There have been apprehensions by manufacturers which are being addressed. This has been a learning experience both for the industry and regulators and the lessons learnt shall be an eye opener.
The infrastructure, in terms of connectivity, uninterrupted power supply, capability and hardware could also pose an issue with several not-so-much developed states and union territories.
The understanding and implementation of the software shall not be a people-centric but it shall be system-driven. There shall be training at all levels of regulatory officials and not confined to few regulators from each state.
It is not clear whether applications for renewals and additional products also will have to go through common software which is most desirable and required. There should be a clear guideline both for regulators and manufacturers for successful implementation.
The CDSCO website can provide a link for dummy run for application of licenses through software and the form shall be devised in such a way that unless and until previous information is filled as per requirements, it shall not allow to fill up the next steps or pop up shall be visible for incomplete/incorrect information. Normally, this is expected and must have been thought of. The website can also think of having a pre-recorded webinar with examples on the use of software for better understanding of manufacturers. The website can also frame FAQs with answers about the entire process.
It is strongly suggested to have minimum one IT professional engaged in each state regulatory office to facilitate the applications and troubleshooting.
Any query with respect to application shall be communicated on official e-mail id provided by the company which is to be responded in set timeframe instead of sending query through formal letter. The minimum requirements of hardware to support this software shall be ensured with every state. The software shall be secured enough to provide confidence to manufacturers.
All stakeholders shall be consulted and taken into confidence before its implementation. There is already such forum formed by DCGI to discuss such matters. Considering the expertise available with manufacturers in computerisation, it shall not be difficult to implement this initiative. The world is moving towards paperless operations, and India shall not be left behind. There are many more digitisation approaches which can be implemented in the time to come with proper guidelines, creation of much-needed infrastructure and developing the capabilities.
Conclusion
The latest proposal for a common software platform for drug licenses management for all the states in the country needs hi-end tech expertise. The industry is hoping to have a glitch-free access to software which will enhance the industry’s capabilities. The CDSCO needs to resolve all the existing technical glitches in the Sugam portal before streamlining the single window magic for all the states.
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